FDA, Stage III and Osimertinib
FDA Expands Approval of Osimertinib in Lung Cancer
The FDA has approved osimertinib (Tagrisso) for locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy, the agency announced Wednesday. The EGFR inhibitor is specifically indicated for adults whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiotherapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations as detected by an FDA-approved test.
FDA Approves Osimertinib in Stage III NSCLC
The approval means an additional indication for osimertinib (Tagrisso; AstraZeneca) for adult patients who have unresectable stage III non–small cell lung cancer (NSCLC) with EGFR mutation.
US FDA approves AstraZeneca’s Tagrisso for patients with unresectable, stage III EGFR-mutated lung cancer
US FDA approves AstraZeneca’s Tagrisso for patients with unresectable, stage III EGFR-mutated lung cancer: Cambridge, UK Friday, September 27, 2024, 11:00 Hrs [IST] AstraZenecas
FDA Approves Osimertinib in Stage III EGFR-Mutated NSCLC
Osimertinib is now an FDA-approved therapy for stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations that did not progress during or following platinum-based chemoradiation.
AZN's Tagrisso Gets FDA Nod for Expanded Use in NSCLC
AstraZeneca AZN announced that the FDA has approved its blockbuster drug, Tagrisso (osimertinib) for expanded use in lung cancer. The regulatory body has approved Tagrisso for the treatment of unresectable,
AstraZeneca gets FDA expanded approval for Tagrisso
AstraZeneca (NASDAQ:AZN) has received FDA approval for its drug Tagrisso for the treatment of patients with unresectable Stage 3 EGFR-mutant non-small cell lung cancer, or NSCLC. The agency approved Tagrisso,
AstraZeneca’s Tagrisso gains FDA approval for stage III NSCLC
Tagrisso, which targets exon 19 deletions or exon 21 (L858R) mutations, received the approval following a priority review.
Medscape1d
FDA Okays Osimertinib After CRT in Locally Advanced, Unresectable NSCLC
The US Food and Drug Administration (FDA) has approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for the treatment ...
Monthly Prescribing Reference2d
Tagrisso Approved for Stage III Unresectable EGFR-Mutated NSCLC
Results showed treatment with osimertinib reduced the risk of disease progression or death by 84% compared with placebo.
Business Wire2d
TAGRISSO ® (osimertinib) approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s TAGRISSO ® (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor ...
Black Diamond Therapeutics' Lead Drug Candidate Shows Initial Anti-tumor Activity In Certain Type Of Lung Cancer Resistant To AstraZeneca's Drug
Black Diamond Therapeutics reports promising initial Phase 2 data for BDTX-1535 in relapsed EGFR-mutant NSCLC patients. With ...
Targeted Oncology4d
Building on the Success of Osimertinib in EGFR-Mutated NSCLC
Suresh S. Ramalingam, MD, FACP, FASCO, discusses the background and next steps of the LAURA study which evaluated osimertinib ...
Israel21c10d
Novel antibody may be key to better lung cancer treatment
Researchers develop synthetic antibody that, when combined with common lung cancer drug, prevents relapse of adenocarcinoma ...
Medical Xpress20d
Osimertinib with savolitinib demonstrates stronger efficacy than osimertinib alone in some patients
The combination of osimertinib and savolitinib showed clinically meaningful improvement in objective response rate compared to osimertinib alone, according to research presented at the ...